Director, Quality Control

Director, Quality Control Watertown, MA | Onsite About The Role

The Director, Quality Control reports to the Senior Director, Quality (Watertown Site Quality Head) and is responsible for providing site-level Quality Control strategy and ensuring the successful operation of the Quality Control function at the Watertown (WTN) site. This role oversees raw material, stability, environmental monitoring (EM), in-process, and release testing programs. The ideal candidate is a hands‑on, innovative leader with strong experience in QC laboratory operations within a GxP-regulated, fast‑paced and customer focused manufacturing environment.

This role directly manages a team of QC professionals.

• Plan and oversee QC laboratory operations, including people management, team development, and ensuring client and manufacturing timelines are met while adhering to the defined QC budget.
• Build, develop, and lead a team of QC analysts and scientists through effective planning, mentoring, directing, and coordination of GMP testing activities.
• Schedule raw material, in-process, release, and stability testing to support the manufacturing schedule.
• Coordinate outsourced laboratory testing and develop strategies to bring testing in-house when appropriate.
• Serve as a subject matter expert in QC testing assays, including both traditional and molecular methodologies.
• Interact with auditors, regulatory inspectors, and clients during site visits and tours.
• Develop and maintain a comprehensive Environmental Monitoring (EM) and utilities monitoring and trending program.
• Coordinate assay validation design and execution, including writing qualification protocols, coordinating execution, and authoring concise technical reports.
• Maintain the integrity of laboratory work areas, including equipment maintenance and calibration, safety, and cleanliness in compliance with established Quality standards.
• Communicate and enforce laboratory quality requirements to all personnel working in the laboratory and ensure compliance with GMP expectations.
• Create, analyze, verify, and approve QC data, results, reports, and Certificates of Analysis (COAs).
• Generate, revise, and review specifications, SOPs, and other QC laboratory and testing documentation.
• Lead Out-of-Specification (OOS), Out-of-Trend (OOT), and Deviation investigations related to the QC laboratory and ensure effective corrective and preventive actions (CAPAs) are implemented.
• Lead and facilitate onboarding, training, and ongoing competency development of QC analysts to ensure adherence to laboratory practices and GMP requirements.
• Prepare and deliver performance reviews, coaching, and performance improvement plans where needed.
• Lead the configuration and implementation of the site LIMS platform in partnership with IT and the broader Quality organization.
• Partner with Quality Assurance, MSAT, Manufacturing, and Site Leadership to drive continuous improvement, inspection readiness, and right-first-time performance across QC operations.

• B.S. or M.S. in a scientific discipline required;
  Ph.D. preferred.
• Minimum of 12–15+ years of progressive Quality Control experience in biologics or GMP-regulated manufacturing environments.
• Director- or Senior Manager-level leadership experience required, with direct people management responsibility.
• Strong experience with cGMP and Quality Systems, including OOS investigations, deviations, change control, and CAPAs.
• Experience with traditional microbiology techniques; anaerobic microbiology experience is a plus.
• Strong experience with analytical and microbiological assay validation, method transfer, and lifecycle management.
• Technical writing experience for investigations, protocols, reports, and regulatory-ready documentation.
• Experience with Environmental Monitoring (EM), utilities monitoring, and contamination control programs.
• Prior experience with LIMS implementation and use preferred.
• Excellent written and verbal communication skills with the ability to interface effectively with clients, auditors, and cross-functional teams.
• High attention to detail, strong organizational skills, and the ability to manage multiple…